Events

Rappel de PREPSTAIN - SLIDE PROCESSOR

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BECTON DICKINSON CANADA INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    24570
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2013-07-19
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    A prepstain system rack setting was incorrectly entered (during a routine preventive maintenance visit) resulting in a tube position with the wrong y offset for rack four only. specifically the y offset had the 12th position mapped to an incorrect tube. the error consisted of a single patient sample being drawn and deposited on four (4) consecutive slides: - patient specimen from tube 1 was deposited on slides 1-4. - patient specimen from tube 5 was deposited on slides 5-8. - patient specimen from tube 9 was deposited on slides 9-12. the error was introduced due to an incorrect keystroke by the bd field service engineer (fse) (human error). the incorrect rack setting led to: - patient samples which were not tested during a test run (specifically each run of 48 patient samples would include 9 patient samples that were not processed) and - incorrect reporting of patient results. the 9 patient test results (not tested) were reported from the other patient specimens.

Device

PREPSTAIN - SLIDE PROCESSOR
  • Modèle / numéro de série
    Model Catalog: 799-13000-00 (Lot serial: >10 contact manufacturer); Model Catalog: 799-14000-00 (Lot serial: >10 contact manufacturer); Model Catalog: 05CR000021 (Lot serial: >10 contact manufacturer); Model Catalog: 490100 (Lot serial: >10 contact manufacturer); Model Catalog: 490407 (Lot serial: >10 contact manufacturer); Model Catalog: 799-13000-00R (Lot serial: >10 contact manufacturer); Model Catalog: 799-14000-00R (Lot serial: >10 contact manufacturer); Model Catalog: 05CR00021R (Lot serial: >10 contact manufacturer)
  • Description du dispositif
    BD PrepStain AG/US-I/US-II
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.